Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206864
Company: NAARI PTE LTD

Products on ANDA 206864

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORETHINDRONE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;1MG	TABLET;ORAL-28	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206864

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/28/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206864

NORETHINDRONE AND ETHINYL ESTRADIOL

TABLET;ORAL-28; 0.035MG;1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALYACEN 1/35	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;1MG	TABLET;ORAL-28	Prescription	No	AB	091634	GLENMARK PHARMS LTD
DASETTA 1/35	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;1MG	TABLET;ORAL-28	Prescription	No	AB	090948	NOVAST LABS LTD
NORETHINDRONE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;1MG	TABLET;ORAL-28	Prescription	No	AB	206864	NAARI PTE LTD
NORETHINDRONE AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;1MG	TABLET;ORAL-28	Prescription	No	AB	070687	WATSON LABS TEVA
NORTREL 1/35-28	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;1MG	TABLET;ORAL-28	Prescription	No	AB	072696	BARR
NYLIA 1/35	ETHINYL ESTRADIOL; NORETHINDRONE	0.035MG;1MG	TABLET;ORAL-28	Prescription	No	AB	207056	AUROBINDO PHARMA